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Coronary DiseaseNCT06744023

Effects of Improved Environment on Sleep, Anxiety-Depression

A study testing To examine the effect of the improved environment according to Watsons Human Care Theory on sleep quality, anxiety, and depression in patients undergoing open heart surgery. in people with Coronary Disease and Cardiovascular Diseases, run by Hatice AZİZOĞLU at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this randomized controlled trial was to examine the effect of an improved environment on sleep, anxiety, and depression in patients undergoing open heart surgery. This study aims to answer the following main questions: According to Watson's Human Care Theory, what is the effect of the improved environment… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Coronary Disease, Cardiovascular Diseases
What is being tested?
To examine the effect of the improved environment according to Watsons Human Care Theory on sleep quality, anxiety, and depression in patients undergoing open heart surgery.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2023to 28 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between the ages of 18 and 65 who have undergone open heart surgery and who are conscious and willing to communicate and cooperate.

Who cannot join

  • Patients younger than 18 years and older than 65 years who did not want to participate in the study voluntarily

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Yüzüncü Yil University

    Van

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Improved Envıronment Accordıng to Watson's Theory of Human Care on Sleep, Anxıety, and Depressıon ın Patıents Undergoıng Open Heart Surgery: A Randomızed Controlled Study

The aim of this randomized controlled trial was to examine the effect of an improved environment on sleep, anxiety, and depression in patients undergoing open heart surgery. This study aims to answer the following main questions:

  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' sleep level and sleep quality?
  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' anxiety and depression levels?

In order to observe the effect of the improved environment on sleep, anxiety, and depression, the researchers ensured that the room temperature, humidity, and lumen range of the light were at the appropriate level in the first 3 days after the surgery of the patients in the experimental group and gradually decreased them gradually.

Read the detailed description

The aim of this randomized controlled trial was to examine the effect of an improved environment on sleep, anxiety, and depression in patients undergoing open heart surgery. This study aims to answer the following main questions:

  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' sleep level and sleep quality?
  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' anxiety and depression levels? Before collecting data for this study, the "G. Power-3.1.9.2" program calculated the sample size at an 80% confidence level. The "Sample Calculation Formula with Known Universe (Population Volume)" (n = Nz2pq / d2(N-1) + z2pq) determined the sample. The literature review determined the "effect size" value to be 0.096. Taking the primary type error of 5% (Z = 1,96), the test power of 80%, and the effect size value of 0,096 units, we calculated the minimum sample size as n = 60. Therefore, the study included 60 volunteer patients, with 30 placed in the experimental group and 30 in the control group.

Data were collected using the Personal Information Form, the Richard-Campbell Sleep Questionnaire (RCSQ), and the Hospital Anxiety and Depression (HAD) Scale.

The patients who underwent open heart surgery and who were in the experimental group were admitted to the ward from the postoperative intensive care unit and the environment was improved for three days based on the improved environment of Watson's HCT, and on the morning of the fourth day in the clinic, the patients were interviewed face to face and the Personal Information Form, RSCQ and HAD Scale were completed. The following improvements were implemented within the scope of environmental improvement:

  • Considering the seasonal conditions, the patient room was ensured to have appropriate temperature (18-26 °C) and humidity values (30-60%), and the temperature and humidity were gradually reduced and maintained in the appropriate range by monitoring at 21:00, 22:00, and 23:00 (Days 1, 2, and 3).
  • In line with the environmental arrangements, the brightness of the light in the patient room was gradually reduced at 21:00, 22:00, and 23:00 using the Light Meter LM-3000 (Days 1, 2, and 3).

Characteristics of the measuring instrument and application

  • The humidity and temperature of the patient room were measured with a Digital-Clock Humidity Meter and Thermometer Device. The Digital-Clock Humidity Meter and Thermometer is a digital thermo-hygrometer that displays indoor temperature and humidity values. The device can stand on the desktop or hang on the wall. The device displays temperature and humidity values, and it also stores the highest and lowest values in its memory. Temperature measurement units can be selected as 0°C or 0°F. The temperature measurement range is -10 to +600, and the accuracy is ± 1 °C. The humidity measurement range of the device with a temperature resolution of 0.1 °C is between 10 and 99%. The humidity sensitivity is ±5%, and the humidity resolution rate is 1%. The device's dimensions are (L) 102 x (W) 21 x (H) 110 mm. It weighed 122 grams.
  • The luminous intensity of the light in the patient room was measured with the Light Meter LM-3000 mobile application provided by the researcher. Luminous intensity is the amount of luminous flux per unit area of a surface per unit time. E represents it, lux serves as its unit, and a luxmeter measures it. By definition, we divide the luminous flux of the surface by its area (E = lumen/m2). Light Meter LM-3000 is a mobile application that measures the illuminance of light in lux. Its measurement algorithm offers unrivaled precision to capture the slightest lighting changes, opening up new possibilities in light pollution and health research. Developed by optical scientists and engineers and compatible with five languages, the Light Meter LM-3000 is calibrated using professional Class A equipment for all iPhones and iPads.

The patients in the control group continued to receive standard treatment and care. On the morning of the fourth day after the patients were admitted to the ward from the postoperative intensive care unit, the patients were interviewed face-to-face and the Personal Information Form, RCSQ, and HAD Scale were completed.

Being tested
To examine the effect of the improved environment according to Watsons Human Care Theory on sleep quality, anxiety, and depression in patients undergoing open heart surgery.
Keywords
Open heart surgery, anxiety, depression, improved environment, sleep quality, sleep duration
Medical subject headings
Coronary Disease, Cardiovascular Diseases, Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • To examine the effect of the improved environment according to Watsons Human Care Theory on sleep quality, anxiety, and depression in patients undergoing open heart surgery.Other

    Also called Improve environment

    The patients who underwent open heart surgery and who were in the experimental group were admitted to the ward from the postoperative intensive care unit and the environment was improved for three days based on the improved environment of Watson's HCT, and on the morning of the fourth day in the clinic, the patients were interviewed face to face and the Personal Information Form, RSCQ and HAD Scale were completed. The following improvements were implemented within the scope of environmental improvement:

    • Considering the seasonal conditions, the patient room was ensured to have appropriate temperature (18-26 °C) and humidity values (30-60%), and the temperature and humidity were gradually reduced and maintained in the appropriate range by monitoring at 21:00, 22:00, and 23:00 (Days 1, 2, and 3)
    • In line with the environmental arrangements, the brightness of the light in the patient room was gradually reduced at 21:00, 22:00, and 23:00 using the Light Meter LM-3000 (Days 1, 2, and 3)
Study groups in NCT06744023
Study groupRoleWhat they receive
EXPERIMENTAL GROUPExperimentalUpon admission to the ward from the postoperative intensive care unit, the experimental group underwent environmental remediation for three days. The environmental arrangements ensured that the patient room maintained an appropriate temperature range of 18-26 °C and humidity values of 30-60%. Monitoring took place at 21:00, 22:00, and 23:00 on Days 1, 2, and 3. On Days 1, 2, and 3, the patient room's light brightness gradually decreased at 21:00, 22:00, and 23:00. On the morning of the fourth day, the patients were interviewed face-to-face, and the research questionnaires were filled out.
Receives: Other: To examine the effect of the improved environment according to Watsons Human Care Theory on sleep quality, anxiety, and depression in patients undergoing open heart surgery.
CONTROL GROUPNo interventionThe patients in the control group continued to receive standard treatment and care. On the morning of the fourth day after the patients were admitted to the ward from the postoperative intensive care unit, the patients were interviewed face-to-face and the Personal Information Form, RCSQ, and HAD Scale were completed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improved sleep quality with optimised environment

    This outcome measure assesses how the improved environment affects postoperative sleep quality with the Richard-Campbell Sleep Questionnaire (RCSQ).

    Measured: The first three days after transfer from intensive care to the ward

  2. Improvement in anxiety levels with improved environment

    This outcome measure assesses how the improved environment affects postoperative anxiety with the Hospital Anxiety and Depression (HAD) Scale.

    Measured: The first three days after transfer from intensive care to the ward

  3. Improvement in depression levels with improved environment

    TThis outcome measure assesses how the improved environment affects postoperative depression with the Hospital Anxiety and Depression (HAD) Scale.

    Measured: The first three days after transfer from intensive care to the ward

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start1 Oct 2023
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomised controlled trial. Upon admission to the ward from the postoperative intensive care unit, the experimental group underwent environmental remediation for three days. The environmental arrangements ensured that the patient room maintained an appropriate temperature range of 18-26 °C and humidity values of 30-60%. Monitoring took place at 21:00, 22:00, and 23:00 on Days 1, 2, and 3. On Days 1, 2, and 3, the patient room's light brightness gradually decreased at 21:00, 22:00, and 23:00. On the morning of the fourth day, the patients were interviewed face-to-face, and the research questionnaires were filled out.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06744023
Sponsor's protocol ID
2023/09-17
Status last verified
Dec 2024
First submitted
20 Jun 2024
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The datasets used to support the findings of this study are available from the corresponding author upon request.

Publications

  • Nicholson G, Gandra SR, Halbert RJ, Richhariya A, Nordyke RJ. Patient-level costs of major cardiovascular conditions: a review of the international literature. Clinicoecon Outcomes Res. 2016 Sep 21;8:495-506. doi: 10.2147/CEOR.S89331. eCollection 2016.

    PubMed 27703385

  • Yin L, Rong T, Zhang Y, Gao J. The relationship between sleep quality and anxiety and depression among older caregivers of centenarians in China: A cross-sectional study. Geriatr Nurs. 2023 Nov-Dec;54:302-309. doi: 10.1016/j.gerinurse.2023.10.005. Epub 2023 Oct 31.

    PubMed 37918038

  • Frontini R, Rebelo-Goncalves R, Amaro N, Salvador R, Matos R, Morouco P, Antunes R. The Relationship Between Anxiety Levels, Sleep, and Physical Activity During COVID-19 Lockdown: An Exploratory Study. Front Psychol. 2021 Mar 30;12:659599. doi: 10.3389/fpsyg.2021.659599. eCollection 2021.

    PubMed 33859601

  • Demir B, Saritas S. The relationship between anxiety and stress levels with quality of sleep in patients after living donor liver transplantation. Transpl Immunol. 2022 Apr;71:101561. doi: 10.1016/j.trim.2022.101561. Epub 2022 Feb 25.

    PubMed 35219827

  • Nyer M, Farabaugh A, Fehling K, Soskin D, Holt D, Papakostas GI, Pedrelli P, Fava M, Pisoni A, Vitolo O, Mischoulon D. Relationship between sleep disturbance and depression, anxiety, and functioning in college students. Depress Anxiety. 2013 Sep;30(9):873-80. doi: 10.1002/da.22064. Epub 2013 May 16.

    PubMed 23681944

  • Tian Y. A review on factors related to patient comfort experience in hospitals. J Health Popul Nutr. 2023 Nov 8;42(1):125. doi: 10.1186/s41043-023-00465-4.

    PubMed 37941052

  • Wei Q, Lee JH, Park HJ. Novel design of smart sleep-lighting system for improving the sleep environment of children. Technol Health Care. 2019;27(S1):3-13. doi: 10.3233/THC-199002.

    PubMed 31045522

  • Delaney LJ, Currie MJ, Huang HC, Lopez V, Van Haren F. "They can rest at home": an observational study of patients' quality of sleep in an Australian hospital. BMC Health Serv Res. 2018 Jul 5;18(1):524. doi: 10.1186/s12913-018-3201-z.

    PubMed 29976191

  • Yelden K, Duport S, Kempny A, Playford ED. A rehabilitation unit at night: environmental characteristics of patient rooms. Disabil Rehabil. 2015;37(1):91-6. doi: 10.3109/09638288.2014.906662. Epub 2014 Apr 1.

    PubMed 24689441

  • Matsumoto Y, Uchimura N, Ishida T, Morimatsu Y, Mori M, Inoue M, Kushino N, Hoshiko M, Ishitake T. The relationship of sleep complaints risk factors with sleep phase, quality, and quantity in Japanese workers. Sleep Biol Rhythms. 2017;15(4):291-297. doi: 10.1007/s41105-017-0110-1. Epub 2017 Jul 21.

    PubMed 28989323

  • Gimenez MC, Geerdinck LM, Versteylen M, Leffers P, Meekes GJ, Herremans H, de Ruyter B, Bikker JW, Kuijpers PM, Schlangen LJ. Patient room lighting influences on sleep, appraisal and mood in hospitalized people. J Sleep Res. 2017 Apr;26(2):236-246. doi: 10.1111/jsr.12470. Epub 2016 Nov 10.

    PubMed 27862514

  • Falci SG, Marques LS. CONSORT: when and how to use it. Dental Press J Orthod. 2015 May-Jun;20(3):13-5. doi: 10.1590/2176-9451.20.3.013-015.ebo. No abstract available.

    PubMed 26154451

  • Norman V, Rossillo K, Skelton K. Creating Healing Environments Through the Theory of Caring. AORN J. 2016 Nov;104(5):401-409. doi: 10.1016/j.aorn.2016.09.006.

    PubMed 27793250

  • Sarrafzadegan N, Mohammmadifard N. Cardiovascular Disease in Iran in the Last 40 Years: Prevalence, Mortality, Morbidity, Challenges and Strategies for Cardiovascular Prevention. Arch Iran Med. 2019 Apr 1;22(4):204-210.

    PubMed 31126179

  • Azizoglu H, Gurkan Z, Bozkurt Y, Demir C, Akaltun H. The Effect of an Improved Environment According to Watson's Theory of Human Care on Sleep, Anxiety, and Depression in Patients Undergoing Open Heart Surgery: A Randomized Controlled Trial. Healthcare (Basel). 2025 Jan 18;13(2):183. doi: 10.3390/healthcare13020183.

    PubMed 39857209

Questions about this trial

What is this clinical trial studying?

A study testing To examine the effect of the improved environment according to Watsons Human Care Theory on sleep quality, anxiety, and depression in patients undergoing open heart surgery. in people with Coronary Disease and Cardiovascular Diseases, run by Hatice AZİZOĞLU at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improved sleep quality with optimised environment (time frame: The first three days after transfer from intensive care to the ward). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06744023, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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